First-in-Human Phase 1 Trial of Agarose Beads Containing Murine RENCA Cells in Advanced Solid Tumors.

Autor:	Smith BH; The Rogosin Institute, Cancer Research, New York, NY, USA., Parikh T; The Rogosin Institute, Cancer Research, New York, NY, USA., Andrada ZP; The Rogosin Institute, Cancer Research, New York, NY, USA., Fahey TJ; New York Presbyterian-Weill Cornell Medical Center, New York, NY, USA., Berman N; New York Presbyterian-Weill Cornell Medical Center, New York, NY, USA., Wiles M; The Rogosin Institute, Xenia Division, Xenia, OH, USA., Nazarian A; The Rogosin Institute, Cancer Research, New York, NY, USA., Thomas J; The Rogosin Institute, Cancer Research, New York, NY, USA., Arreglado A; The Rogosin Institute, Cancer Research, New York, NY, USA., Akahoho E; The Rogosin Institute, Cancer Research, New York, NY, USA., Wolf DJ; The Rogosin Institute, Cancer Research, New York, NY, USA., Levine DM; The Rogosin Institute, Cancer Research, New York, NY, USA., Parker TS; The Rogosin Institute, Cancer Research, New York, NY, USA., Gazda LS; The Rogosin Institute, Xenia Division, Xenia, OH, USA., Ocean AJ; New York Presbyterian-Weill Cornell Medical Center, New York, NY, USA.
Jazyk:	angličtina
Zdroj:	Cancer growth and metastasis [Cancer Growth Metastasis] 2016 Aug 02; Vol. 9, pp. 9-20. Date of Electronic Publication: 2016 Aug 02 (Print Publication: 2016).
DOI:	10.4137/CGM.S39442
Abstrakt:	Purpose: Agarose macrobeads containing mouse renal adenocarcinoma cells (RMBs) release factors, suppressing the growth of cancer cells and prolonging survival in spontaneous or induced tumor animals, mediated, in part, by increased levels of myocyte-enhancing factor (MEF2D) via EGFR-and AKT-signaling pathways. The primary objective of this study was to determine the safety of RMBs in advanced, treatment-resistant metastatic cancers, and then its efficacy (survival), which is the secondary objective. Methods: Thirty-one patients underwent up to four intraperitoneal implantations of RMBs (8 or 16 macrobeads/kg) via laparoscopy in this single-arm trial (FDA BB-IND 10091; NCT 00283075). Serial physical examinations, laboratory testing, and PET-CT imaging were performed before and three months after each implant. Results: RMBs were well tolerated at both dose levels (mean 660.9 per implant). AEs were (Grade 1/2) with no treatment-related SAEs. Conclusion: The data support the safety of RMB therapy in advanced-malignancy patients, and the preliminary evidence for their potential efficacy is encouraging. A Phase 2 efficacy trial is ongoing.
Databáze:	MEDLINE
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